UNKNOWN TED UNK TED

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2013-07-02 for UNKNOWN TED UNK TED manufactured by Covidien, Covidien Mfg.

Event Text Entries

[3651961] It was reported to covidien on (b)(4) 2013 that a customer had an issue with a compression stocking. The customer reports the ted caused damage and necrosis to the pt's skin. The pt wore the stocking from 24-48 hours.
Patient Sequence No: 1, Text Type: D, B5


[10880371] Submit date: (b)(4) 2013. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3009211636-2013-00002
MDR Report Key3213269
Report Source01,06
Date Received2013-07-02
Date of Report2013-06-06
Report Date2013-06-06
Date Reported to Mfgr2013-06-06
Date Mfgr Received2013-06-06
Date Added to Maude2013-07-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactEDWARD ALMEIDA
Manufacturer Street15 HAMPSHIRE ST.
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524151
Manufacturer G1COVIDIEN MANUFACTURING SOLUTIONS SA
Manufacturer StreetEDIFICIO 820 CALLE #2 ZONA FRANCA COYOL
Manufacturer CityALAJUELA 20101
Manufacturer CountryCS
Manufacturer Postal Code20101
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN TED
Generic NameCOMPRESSION STOCKING
Product CodeDWL
Date Received2013-07-02
Model NumberUNK TED
Catalog NumberUNK TED
Lot NumberUNK
ID NumberNA
OperatorOTHER
Device AvailabilityN
Device AgeNA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN, COVIDIEN MFG
Manufacturer AddressALAJUELA 20101 CS 20101


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-07-02

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